Garnier Ombrelle Ultra Light Advanced Broad Spectrum SPF 50 Plus Sunscreen Water Resistant 80 Minutes Weightless Body by L'OREAL USA PRODUCTS INC / Dimensional Merchandising Inc. Drug Facts

Garnier Ombrelle Ultra Light Advanced Broad Spectrum SPF 50 Plus Sunscreen Water Resistant 80 Minutes Weightless Body by

Drug Labeling and Warnings

Garnier Ombrelle Ultra Light Advanced Broad Spectrum SPF 50 Plus Sunscreen Water Resistant 80 Minutes Weightless Body by is a Otc medication manufactured, distributed, or labeled by L'OREAL USA PRODUCTS INC, Dimensional Merchandising Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GARNIER OMBRELLE ULTRA LIGHT ADVANCED BROAD SPECTRUM SPF 50 PLUS SUNSCREEN WATER RESISTANT 80 MINUTES WEIGHTLESS BODY- avobenzone, ecamsule, homosalate, octisalate, octocrylene and oxybenzone lotion
L'OREAL USA PRODUCTS INC

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Drug Facts

Active ingredients

Avobenzone 3%
Ecamsule 2%
Homosalate 10%
Octisalate 5%
Octocrylene 5%,
Oxybenzone 6%

Warnings

For external use only. Do not use on broken skin. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or
contact a poison control centre right away.

Directions

Adults and children 6 months and up. Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours, after 80 minutes of swimming or sweating and immediately after towel drying.

Inactive ingredients

aqua, cyclopentasiloxane, alcohol denat., cyclohexasiloxane, styrene/acrylatescopolymer, silica, dicaprylyl ether, PEG-30 dipolyhydroxystearate, dimethicone, triethanolamine, glycerin, nylon-12 polymet h y l s i lsesquioxane, dicaprylyl carbonate, tocopherol, dodecene, phenoxyethanol, PEG-8 laurate, poly C10-30 alkyl acrylate, poloxamer 407, caprylyl glycol, disteardimonium hectorite, disodium EDTA, lauryl PEG/PPG-18/18 methicone

image of a carton

GARNIER OMBRELLE ULTRA LIGHT ADVANCED BROAD SPECTRUM SPF 50 PLUS SUNSCREEN WATER RESISTANT 80 MINUTES WEIGHTLESS BODY
avobenzone, ecamsule, homosalate, octisalate, octocrylene and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-833
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439)	ECAMSULE	20 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALCOHOL (UNII: 3K9958V90M)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
NYLON-12 (UNII: 446U8J075B)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
TOCOPHEROL (UNII: R0ZB2556P8)
DODECENE (UNII: WYE669F3GR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-8 LAURATE (UNII: 762O8IWA10)
POLOXAMER 407 (UNII: TUF2IVW3M2)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 49967-833-01	1 in 1 CARTON	03/22/2017	08/30/2022
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
export only		03/22/2017	08/30/2022

Labeler - L'OREAL USA PRODUCTS INC (002136794)

Name	Address	ID/FEI	Business Operations
Establishment
Dimensional Merchandising Inc.		076693183	manufacture(49967-833) , pack(49967-833)

Revised: 1/2023

Document Id: faf7e36b-c0c9-441f-ad48-3b1564a834a6

Set id: 6ab7dd16-4f83-4af2-9936-f428c686e014

Version: 2

Effective Time: 20230126